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Merck NYSE:MRK and Daiichi Sankyo TSE:4568 have voluntarily withdrawn their US application seeking accelerated approval for their experimental lung cancer therapy, the companies said on Friday.The decision followed discussions with the US Food and Drug Administration, which determined that the data…
Merck NYSE:MRK and Daiichi Sankyo TSE:4568 have voluntarily withdrawn their US application seeking accelerated approval for their experimental lung cancer therapy, the drugmakers said on Friday.
The companies said the U.S. biologics license application for ifinatamab deruxtecan in previously treated extensive-stage small cell lung cancer was voluntarily withdrawn after discussions with the FDA. They said data from the phase 2 trial did not meet requirements for accelerated approval.
The companies said the U.S. biologics license application for ifinatamab deruxtecan in previously treated extensive-stage small cell lung cancer was voluntarily withdrawn after discussions with the FDA. Enrollment continues in a Phase 3 trial of the drug in relapsed ES-SCLC.